Label: POVI-ONE- povidone-iodine 10% topical liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 57511-0610-1 - Packager: Elevate Oral Care
- This is a repackaged label.
- Source NDC Code(s): 0395-2325
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 3, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts Active Ingredient
- Uses
- Warnings For External Use Do Not Use
- Stop Use and Ask A Doctor
- Keep Out of Reach of Children
- Directions
- Other Information
- Inactive Ingredients
- Contents
- Questions?
- Instructions For Use:
- Drug Facts Panel
- Povi-One Solution 0.2ml X 6 Ampules NDC: 57511-0610-1
-
INGREDIENTS AND APPEARANCE
POVI-ONE
povidone-iodine 10% topical liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57511-0610(NDC:0395-2325) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) NONOXYNOL-2 (UNII: U4A966MO25) WATER (UNII: 059QF0KO0R) Product Characteristics Color brown (liquid) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57511-0610-1 6 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product 05/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/02/2022 Labeler - Elevate Oral Care (002863526) Registrant - Elevate Oral Care (002863526) Establishment Name Address ID/FEI Business Operations Elevate Oral Care 002863526 relabel(57511-0610) , repack(57511-0610)